Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-02-20 @ 11:49 PM
Study NCT ID:
NCT06644469
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-18
First Post:
2024-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole Body Vibration in Middle Aged Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018908', 'term': 'Muscle Weakness'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The participants will be unaware of whether they are receiving vibration therapy, and the individual performing the assessment will be different from the one administering the treatment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2024-10-14', 'studyFirstSubmitQcDate': '2024-10-14', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone Density', 'timeFrame': '8 weeks', 'description': 'Changes in BMD (measured by DXA scanner),'}, {'measure': 'Grip Strength', 'timeFrame': '8 weeks', 'description': 'hand grip strength (measured by a hand-held dynamometer)'}, {'measure': 'Vitamin D', 'timeFrame': '8 weeks', 'description': 'Vitamin D levels (measured by high-performance liquid chromatography).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pilot Study', 'Bone Density', 'Vibration Therapy', 'Vitamin D', 'Muscle Strength'], 'conditions': ['Bone Density', 'Muscle Weakness']}, 'descriptionModule': {'briefSummary': 'This study aims of this clinical trial is to evaluate the effect of an 8-week Whole Body Vibration (WBV) intervention on Bone Mineral Density (BMD), hand grip strength, and vitamin D levels in middle-aged men. Findings from this study will contribute to understanding whether WBV is a viable alternative to conventional exercise, especially for those with limitations in physical activity.\n\nStudy Objectives:\n\n• Primary Objective: To assess the effectiveness of an 8-week WBV intervention in improving BMD, hand grip strength, and vitamin D levels compared to a placebo intervention.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male participants aged 50 years or older\n* Participants with physical activity or exercise program involvement\n* Participants with no history of serious medical conditions such as tumors, fractures, epilepsy, cardiac disease, or stroke within the past year.\n* Participants must be non-smokers and not receiving hormone or calcium supplement therapy\n\nExclusion Criteria:\n\n* Participants unable to stand on the WBV platform\n* Participants with conditions contraindicating vibration therapy\n* Participants participating in other clinical trials'}, 'identificationModule': {'nctId': 'NCT06644469', 'briefTitle': 'Whole Body Vibration in Middle Aged Men', 'organization': {'class': 'OTHER', 'fullName': 'Jouf University'}, 'officialTitle': 'Effects of Whole-Body Vibration on Bone Mineral Density, Hand Grip Strength, and Vitamin D Levels in Middle-Aged Men: a Preliminary Clinical Trial', 'orgStudyIdInfo': {'id': 'JoufU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group with placebo vibration therapy', 'description': 'Participants will perform the same activities as the experimental group, but with a vertical displacement of 0.22 mm, deemed therapeutically insufficient.', 'interventionNames': ['Device: Placebo Dynatronics VF5 Model vibration platform']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Participants will undergo an 8-week WBV therapy program using a Dynatronics VF5 Model vibration platform. Each session will last 4 minutes, with vibration frequencies progressively increased from 25 Hz to 40 Hz without rest intervals.', 'interventionNames': ['Device: Dynatronics VF5 Model vibration platform']}], 'interventions': [{'name': 'Dynatronics VF5 Model vibration platform', 'type': 'DEVICE', 'description': 'The Dynatronics VF5 Model vibration platform is a specialized therapeutic device designed for rehabilitation and wellness applications. Utilizing advanced vibration technology, it provides whole-body vibration therapy that can enhance muscle strength, improve flexibility, and promote overall physical well-being. The platform features adjustable frequency and amplitude settings, allowing customization based on individual needs. Its user-friendly interface and robust, durable design make it suitable for both clinical and mobile therapy settings. Additionally, the compact and portable nature of the VF5 facilitates easy storage and transport, while safety features such as non-slip surfaces ensure user protection.', 'armGroupLabels': ['Experimental Group']}, {'name': 'Placebo Dynatronics VF5 Model vibration platform', 'type': 'DEVICE', 'description': 'Placebo intensity with vertical vibration of 0.2 mm', 'armGroupLabels': ['Control Group with placebo vibration therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77634', 'city': 'Sakakah', 'state': 'Aljouf', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Khalid Alrwaily Mr, BPT', 'role': 'CONTACT', 'email': 'K.Alrwaily@moh.edu.sa', 'phone': '+966543944811'}, {'name': 'Fahad Alanazi Dr Assitant professor, PhD', 'role': 'CONTACT'}], 'facility': 'prince Mutaib bin Abdulaziz hospital', 'geoPoint': {'lat': 29.96974, 'lon': 40.20641}}], 'centralContacts': [{'name': 'Fahad Alanazi, PhD', 'role': 'CONTACT', 'email': 'Fsalenezi@ju.edu.sa', 'phone': '00966503409217'}], 'overallOfficials': [{'name': 'Fahad Alanazi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jouf University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'all IPD that underlie results in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jouf University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Fahad Alanazi', 'investigatorAffiliation': 'Jouf University'}}}}